BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH
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Model Number 500-56150 |
Device Problems
Leak/Splash (1354); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Event Description
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It was reported that ekos therapy was discontinued as a result of a leak, and the patient did not receive an adequate amount of lytic.An ekosonic endovascular device, 135x50cm was selected for use.During ekos therapy, an overheating alarm sounded, and upon moving the patient, it was noted that the hub of the ekos device was leaking.It was unconfirmed whether the leak was attributed to coolant or lytic, but the physician believed the leak to be lytic.Ultrasound therapy was discontinued, and the ekos device was continued to be used as a standard infusion catheter, despite the leak.Thrombus resolution was not achieved, and the physician reported that the patient did not receive an adequate amount of lytic.There were no reported patient complications.
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Event Description
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It was reported that ekos therapy was discontinued as a result of a leak, and the patient did not receive an adequate amount of lytic.An ekosonic endovascular device, 135x50cm was selected for use.During ekos therapy, an overheating alarm sounded, and upon moving the patient, it was noted that the hub of the ekos device was leaking.It was unconfirmed whether the leak was attributed to coolant or lytic, but the physician believed the leak to be lytic.Ultrasound therapy was discontinued, and the ekos device was continued to be used as a standard infusion catheter, despite the leak.Thrombus resolution was not achieved, and the physician reported that the patient did not receive an adequate amount of lytic.There were no reported patient complications.
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Manufacturer Narrative
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Device analysis: visual inspection of the complaint device confirmed that there was a crack in the manifold luer.Functional testing confirmed that liquid was leaking from the crack.The reported event of leaking was confirmed.Additionally, it was found that the manifold luer was cracked.The reported event of an overheating alarm was not confirmed, but it was likely that leaking coolant from the manifold led to insufficient coolant irrigation, and a temperature alarm.
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